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西药 · 美国药品标签原文

埃索美拉唑 · Esomeprazole magnesium

ESOMEPRAZOLE MAGNESIUM

Esomeprazole magnesium · TIME CAP LABORATORIES, INC.。此记录对应特定产品,标签收录不代表所有用途获批。

说明与适用边界

此页按所列地区、版本归档。标签内容可能更新,具体产品请核对原始来源;本站关联表示阅读线索,不表示药品与器械可兼容或可替换。

spl product data elements

Esomeprazole magnesium esomeprazole magnesium SUCROSE DIMETHICONE FERROSOFERRIC OXIDE METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) HYPROMELLOSES POTASSIUM HYDROXIDE FD&C BLUE NO. 1 GELATIN GLYCERYL MONOSTEARATE HYDROXYPROPYL CELLULOSE, UNSPECIFIED POLYSORBATE 80 SHELLAC SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE TRIETHYL CITRATE FD&C RED NO. 3 FERRIC OXIDE YELLOW MAGNESIUM STEARATE ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE 75 PURPLE (golden cap and violet transparent body having light violet to violet colour band)

spl unclassified section

Drug Facts

活性成分 / Active ingredient

Active ingredient (in each capsule) Esomeprazole 20 mg (Each delayed-release capsule corresponds to 22.3 mg esomeprazole magnesium trihydrate)

用途 / Purpose

Purpose Acid reducer

适应证 / Indications and usage

Uses treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

警告 / Warnings

Warnings Allergy alert Do not use if you are allergic to esomeprazole Esomeprazole may cause severe skin reactions. Symptoms include: -skin reddening -blisters -rash If an allergic reaction occurs, stop use and seek medical attention right away.

禁用事项 / Do not use

Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools heartburn with lightheadedness, sweating or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness frequent chest pain These may be signs of a serious condition. See your doctor.

咨询医生 / Ask a doctor

Ask a doctor before use if you have had heartburn over 3 months. This may be a sign of a more serious condition. frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain

咨询医药人员 / Ask a doctor or pharmacist

Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.

停用事项 / Stop use

Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days you need to take more than 1 course of treatment every 4 months you get diarrhea you develop a rash or joint pain

孕哺期 / Pregnancy or breastfeeding

If pregnant or breast-feeding, ask a health professional before use.

儿童安全 / Keep out of reach of children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

用法用量原文 / Dosage and administration

Directions adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days may take 1 to 4 days for full effect 14-Day Course of Treatment swallow 1 capsule with a glass of water before eating in the morning take every day for 14 days do not take more than 1 capsule a day swallow whole. Do not crush or chew capsules. do not use for more than 14 days unless directed by your doctor Repeated 14-Day Courses (if needed) you may repeat a 14-day course every 4 months do not take for more than 14 days or more often than every 4 months unless directed by a doctor children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition.

其他安全资料 / Other safety information

Other information read the directions and warnings before use keep the carton. It contains important information. store at 20-25°C (68-77°F)

辅料 / Inactive ingredients

Inactive ingredients black iron oxide, eudragit, FD&C blue 1, FD&C red 3, ferric oxide yellow, gelatin, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, polysorbate 80, potassium hydroxide, shellac, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate.

questions

Questions or comments? Call 1-877-290-4008

package label principal display panel

718T-Esomeprazole-42ct-carton 718T-Esomeprazole-14ct-label

来源、版本与许可

资料类型
美国药品标签原文
版本
1 / 20231123
获取时间
2026-10-08
许可
openFDA public data; retain original label attribution. See 查看来源 and dataset source notices. Public access does not imply approval or unrestricted rights to every submitted label.
核对原始来源